FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SECURE-ON-TOUCH
K Number: K820092
·
Decision Feb 24, 1982
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
15
Review Days
42
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SECURE-ON-TOUCH
- K Number
- K820092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sci-Pharm, Inc.
- Date Received
- January 13, 1982
- Decision Date
- February 24, 1982
- Product Code
- DYH
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYH), ordered by most recent decision date.
BracePaste Prime Plus
FDA 510(k)
FDA Class 2
·Dental
Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
FDA 510(k)
FDA Class 2
·Dental
BracePaste Fluoride Sealant
FDA 510(k)
FDA Class 2
·Dental
3M Transbond Orthodontic Adhesive
FDA 510(k)
FDA Class 2
·Dental
AlignerFlow LC
FDA 510(k)
FDA Class 2
·Dental
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Sci-Pharm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823935 | MICRO JOIN, CROWN & BRIDGE ADHESIVE | Feb 7, 1983 | Substantially Equivalent |
| K813091 | FISSURE SEALER & BONDING AGENT | Nov 24, 1981 | Substantially Equivalent |
| K813090 | COMPOSITE DENTAL RESTORATIVE MATERIAL | Nov 24, 1981 | Substantially Equivalent |
| K812550 | BEAUCAV | Sep 25, 1981 | Substantially Equivalent |
| K812545 | BEAUFILL | Sep 25, 1981 | Substantially Equivalent |
| K812546 | BEAUDENT | Sep 25, 1981 | Substantially Equivalent |
| K812548 | COBEAU | Sep 25, 1981 | Substantially Equivalent |
| K812549 | BEAUSEAL | Sep 25, 1981 | Substantially Equivalent |
| K812551 | BEAUCOR | Sep 23, 1981 | Substantially Equivalent |
| K812547 | BEAUBON | Sep 23, 1981 | Substantially Equivalent |